- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07680127
TENS of Auricular Vagal Nerve for Radiation Necrosis
25 giugno 2026 aggiornato da: Virginia Commonwealth University
Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema.
In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2).
Patients in both arms will have imaging performed and tissue and blood collected for assessment of changes in area of contrast enhancement and cerebral edema, inflammatory markers, and markers of blood-brain barrier permeability.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Amy Erickson
- Numero di telefono: 804-828-9165
- Email: amy.erickson@vcuhealth.org
Luoghi di studio
-
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Virginia
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University
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Contatto:
- Amy Erickson
- Numero di telefono: 804-828-9165
- Email: amy.erickson@vcuhealth.org
-
Investigatore principale:
- Ryan Cleary, MD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- History of glioma or metastatic brain lesion previously treated with whole brain radiation, stereotactic radiation surgery, or fractionated radiation therapy
- Magnetic resonance imaging (MRI) findings consistent with possible radiation necrosis within 6 weeks prior to enrollment.
- Candidate for tissue biopsy and Laser Interstitial Thermal Therapy (LITT) ablation of the lesion
- At least 18 years of age
- If on corticosteroids, able to discontinue at least 5 days prior to start of transcutaneous auricular vagus nerve stimulation (taVNS) (Arm 1) or sham treatment (Arm 2). A stable physiologic dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the investigator. 6. Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
- New onset neurologic deficits secondary to radiation necrosis requiring initiation of dexamethasone therapy or other intervention prior to enrollment
- Currently receiving bevacizumab for treatment of radiation necrosis or has received bevacizumab < 6 weeks prior to study enrollment.
- Currently receiving any investigational agents for treatment of radiation necrosis or has participated in a study of an investigational agent for radiation necrosis within 3 weeks prior to study enrollment.
- History of cardiac conduction disorders or presence of implanted electronic devices
- Active Crohn's disease or other inflammatory bowel disease.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore fittizio: Falso
|
TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear, with no stimulation twice daily for 12 to 14 days prior to planned LITT ablation.
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Sperimentale: Stimolazione auricolare transcutanea del nervo vagale (taVNS)
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Transcutaneous auricular vagal nerve stimulation (taVNS) stimulation twice daily for 12 to 14 days prior to planned LITT ablation via TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker TNF-alpha utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in (IL-12) serum inflammatory marker utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker GMCSF utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IFN gamma utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-1b utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin-10 (IL-10)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-10 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 13 (IL-13)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-13 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin (IL-2)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-2 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory markers interleukin 17 (IL-17A)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-17A utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 4 (IL-4)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-4 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 5 (IL-5)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-5 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 6 (IL-6)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-6 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 8 (IL-8)
Lasso di tempo: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-8 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
Lasso di tempo: Baseline, and 2 weeks following intervention
|
Percent change of NFL marker of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
|
Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment
Lasso di tempo: Baseline, and 2 weeks following intervention
|
Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
|
Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
Lasso di tempo: Baseline, and 2 weeks following intervention
|
Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
|
Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Lasso di tempo: Baseline, and 2 weeks following intervention
|
Percent change of BBB permeability
|
Baseline, and 2 weeks following intervention
|
|
Assess interval changes in radiation necrosis on MRI after treatment w taVNS
Lasso di tempo: Baseline, and 2 weeks following intervention
|
Percent changes in areas of contrast enhancement and perilesional T2-weighted fluid-attenuated inversion recovery (T2/FLAIR) Hypersensitivity on magnetic resonance imaging (MRI).
On these images, areas with higher water content suck as edema, inflammation, or demyelination, appear brighter compared to surrounding tissue.
|
Baseline, and 2 weeks following intervention
|
|
Assess interval changes in cerebral edema on MRI after treatment
Lasso di tempo: Baseline, and 2 weeks following intervention
|
Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI
|
Baseline, and 2 weeks following intervention
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Ryan Cleary, MD, Virginia Commonwealth University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
31 luglio 2026
Completamento primario (Stimato)
31 agosto 2029
Completamento dello studio (Stimato)
31 agosto 2029
Date di iscrizione allo studio
Primo inviato
25 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
25 giugno 2026
Primo Inserito (Effettivo)
2 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MCC-25-22821
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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